36-Month Post-marketing Surveillance and Analysis of Menactra Vaccine in 2-10 Year Olds

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1421 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2013-05-31

Brief Summary

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To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.

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Detailed Description

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Conditions

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Meningitis Meningococcal Disease

Study Design

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Observational Model Type

COHORT

Study Groups

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Menactra Vaccine Recipients

Children 2 years through 10 years of age who received Menactra vaccine within Kaiser Permanente during the study period. They served as their own controls for evaluation of acute (Days 0-30) events. Rates of events occurring during Days 0-30 following vaccination were compared to rates of events occurring during Days 31-60 following vaccination.

Six-month surveillance: For each individual receiving Menactra vaccine, the rate of an event in the 30-day follow-up period was compared with the rate of the same event in the 31-180-day follow-up period using age, sex, and seasonality as covariates in Cox regression analyses.

Menactra vaccine was administered according to routine clinical practice.